The following data is part of a premarket notification filed by Ansell Intl. with the FDA for Sensiderm.
| Device ID | K904244 |
| 510k Number | K904244 |
| Device Name: | SENSIDERM |
| Classification | Surgeon's Gloves |
| Applicant | ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
| Contact | Paul Cacioli |
| Correspondent | Paul Cacioli ANSELL INTL. LOT 80, AIR KEROH IND. EST. Melaka, MT 75150 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-14 |
| Decision Date | 1991-02-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENSIDERM 79119888 4427082 Live/Registered |
Electrophoretics Limited 2012-07-03 |
![]() SENSIDERM 73178907 1115116 Dead/Cancelled |
PPRL, INC. 1978-07-20 |